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Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Dow
Merck
McKinsey
US Army
Medtronic
QuintilesIMS
Baxter
Mallinckrodt

Generated: October 17, 2017

DrugPatentWatch Database Preview

Lenalidomide - Generic Drug Details

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What are the generic sources for lenalidomide and what is the scope of lenalidomide patent protection?

Lenalidomide
is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are twenty-seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lenalidomide has four hundred and ninety-four patent family members in forty-five countries and seventeen supplementary protection certificates in twelve countries.

There are twelve drug master file entries for lenalidomide. One supplier is listed for this compound.

Summary for Generic Name: lenalidomide

US Patents:27
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list12
Suppliers / Packagers: see list1
Bulk Api Vendors: see list87
Clinical Trials: see list743
Patent Applications: see list572
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lenalidomide at DailyMed

Pharmacology for Ingredient: lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005RXYesNo► Subscribe► SubscribeYY ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006RXYesNo► Subscribe► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006RXYesNo► Subscribe► SubscribeYY ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 2011RXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 2011► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 2013► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 2013► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lenalidomide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,335,349 Substituted 2(2,6-dioxopiperidin-3-yl)isoindolines► Subscribe
9,365,538Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► Subscribe
7,354,948Methods for treatment of chronic uveitis using cyclopropyl-n-{2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)eth- yl]-3-oxoisoindoline-4-yl}carboxamide► Subscribe
8,673,939Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione► Subscribe
8,759,375Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione in combination with proteasome inhibitor► Subscribe
9,498,472Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias► Subscribe
7,959,566Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated► Subscribe
7,393,862Method using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias► Subscribe
6,869,399 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated► Subscribe
9,662,321Methods for treating newly diagnosed multiple myeloma with 3-(4-amino-1-OXO-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with second active agents► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: lenalidomide

Country Document Number Estimated Expiration
Denmark2426118► Subscribe
Taiwan200501945► Subscribe
South Korea20000068008► Subscribe
New Zealand541736► Subscribe
Ukraine60308► Subscribe
Mexico2009001268► Subscribe
Canada2291218► Subscribe
Slovenia1667682► Subscribe
Cyprus1115782► Subscribe
South Korea20050053769► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LENALIDOMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2 50002-2015Slovakia► SubscribePRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
C0056France► SubscribePRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070614
2007 00054Denmark► Subscribe
0925294/01Switzerland► SubscribePRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
56/2007Austria► SubscribePRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES
90004-6Sweden► SubscribePRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
2015000013Germany► SubscribePRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
359Luxembourg► Subscribe91359, EXPIRES: 20220614
2015 00006Denmark► SubscribePRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
0150005 00140Estonia► SubscribePRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Teva
Accenture
AstraZeneca
Harvard Business School
Fish and Richardson
Colorcon
Medtronic
QuintilesIMS
Julphar
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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